The Innovative and Entrepreneurial Culture – Examples in Healthcare Richard M. Satava, MD FACS Professor of Surgery University of Washington Innovation Forum Innovation Opportunities in Health University of Saskachewan Saskatoon, Saskachewan 13-15 September,
Download ReportTranscript The Innovative and Entrepreneurial Culture – Examples in Healthcare Richard M. Satava, MD FACS Professor of Surgery University of Washington Innovation Forum Innovation Opportunities in Health University of Saskachewan Saskatoon, Saskachewan 13-15 September,
The Innovative and Entrepreneurial Culture – Examples in Healthcare Richard M. Satava, MD FACS Professor of Surgery University of Washington Innovation Forum Innovation Opportunities in Health University of Saskachewan Saskatoon, Saskachewan 13-15 September, 2009 Presenter Financial Disclosure Slide Richard M. Satava, MD FACS Financial Support: None (… but still hoping) Consulting: Karl Storz ISIS Support Stryker SimuLab US Surgical Investment InTouch Technologies, Inc * There will be no discussion of products from these companies Greetings from Monterey California Storytelling Johns Hopkins Disruptive Visions “The Future is not what it used to be” ….Yogi Berra Current Visions “The Future is here … . . . it’s the Information Age” Entering a New The “Fourth Wave” ?? Clayton M Christensen TECHNOLOGY DEVELOPMENT BIO-INTELLIGENCE AGE CONSUMER ACCEPTANCE Fourth Wave? 2000 BC 0 1500 1800 1900 2000 AD TIME (year) Satava 29 July 99 BIO-INTELLIGENCE AGE BIOLOGIC Biosensors Biomaterials Biomimetic PHYSICAL FUTURE Genomics Bioinformatics Biocomputation Robotics HPCC/WWW MEMS/Nano INFORMATION Satava 2 Feb 1999 Creating a New Age Pioneers Inventors Implement Discover The Future Entrepreneurship Innovators Adopt Satava 2 Feb 1999 The Scientific Method Evidence Based Medicine is . . . The Scientific Method as Applied to Medicine The Evidence IS the Science In order to accept evidence-based medicine . . . we must accept the current method in Science What is Science ? . . . study that relate(s) to the phenomena of the material universe and their laws Oxford English Dictionary Science is what we observe by using the Scientific Method METHODS Classical Period Renaissance Observation phenomenon Aristotle Archimedes DaVinci Michelangelo Age of Enlightenment experiment Newton Boyle Industrial Age scientific method Einstein Fermi Information Age …? Hawking Wolfram What is the Controversy? Wisdom of Giants Evidence Creativity of Innovators Imagination THE STRUCTURE OF SCIENTIFIC REVOLUTIONS The Great Debate 4 Decades of The Logic of Scientific Discovery Kuhn vs Popper THOMAS S. KUHN Science is Evolving . . . and so is the Scientific Method METHODS Classical Period Renaissance Age of Enlightenment Observation phenomenon experiment Aristotle Archimedes DaVinci Michelangelo Newton Boyle Industrial Age scientific method Einstein Fermi Information Age …? Hawking Wolfram A Scientific Revolution occurs with a Breakthrough or “Crisis” in Knowledge …and a New Era emerges . . . and with each New Era a new method of discovery METHODS Classical Period Renaissance Age of Enlightenment Observation phenomenon experiment Aristotle Archimedes DaVinci Michelangelo Newton Boyle Industrial Age scientific method Einstein Fermi Information Age …? Hawking Wolfram Scientific Method . . . . . . is DEAD? Not necessarily but ... Not all science is explainable using the scientific method Where is the role of Imagination Innovation Serendipity Intuition Creativity Inspiration FURTHER PROOF: Current evidence is inadequate for Event horizons Cognition Genome Quantum mechanics Memes Etc New discoveries evolve from Emergent Properties S The Industry Standard I CAD/CAM M U Virtual Design L A T Virtual Prototyping I O N Virtual Testing & Evaluation W here Is the Scientific Method failing us? Hypothesis Study Design Experiment Results Reporting 1. Where does the hypothesis come from? ? Creativity Intuition Inspiration Hypothesis Study Design Experiment Results Reporting Analogy & Metaphor Exception-to-the-rule Emergent properties Outliers, etc “We don’t know … what we don’t know” 2. Can all evidence be demonstrated by Randomized, controlled, double-blind trials? Yogi Berra How has the Scientific Method changed ? Hypothesis Study Design Experiment Results Reporting Simulation ? Creativity Intuition Inspiration Hypothesis Study Design Experiment Simulation Analogy & Metaphor Exception-to-the-rule Emergent Properties Outliers, etc n= 108 Results Reporting Where is the Scientific Method failing us? Hypothesis Study Design Experiment Results Reporting 2. Can all evidence be demonstrated by Randomized, controlled, double-blind trials? SCIENTIFIC METHOD Controlled, randomized, double-blind trial Control Group No Parachute Still looking for volunteers for the control group Test Group Parachute $ Government Funding $ What Reseachers Need to Know Role of the Crossing Innovator the Chasm Role Innovator of the Crossing the The Second Chasm Valley of Death Inventor Technology Enthusiast Inventor Early Innovators Visionaries Innovator Early Adopters Pragmatic Pioneer Chasm ( Tech Transfer ) (Sustainment) Pioneer Innovator Inventor Design TRL 1 2 3 4 5 Transition 6 7 Scientific Method 8 9 Gartner’s Hype Cycle of Innovation VISIBILITY TIME Technology Trigger Peak of Inflated Expectations Trough of Disillusionment Slope of Enlightenment Plateau of Productivity The Innovator Must See the “big picture” Understand the “science” Possess entrepreneurship Transition the technology The inventor ... Discovers The pioneer ... Adopts but The innovator ... crosses the chasm …. Twice Research New Idea Product Disposal Technology Readiness Levels Technology Readiness Level Description This is the lowest "level" of technology maturation. At this level, scientific 1. Basic principles observed and reported research begins to be translated into applied research and development. Once basic physical principles are observed, then at the next level of maturation, practical applications of those 2. Technology concept and/or application characteristics can be 'invented' or formulated identified. At this level, the application is still speculative: there is not experimental proof or detailed analysis to support the conjecture. At this step in the maturation process, active research and development (R&D) is initiated. This must include both analytical studies to set the technology 3. Analytical and experimental critical into an appropriate context and function and/or characteristic proof of laboratory-based studies to physically concept validate that the analytical predictions are correct. These studies and experiments should constitute "proof-of-concept" validation of the applications/concepts TRL 1 2 3 4 5 Transition 6 Clinical Trials 7 8 Scientific Method 9 The Innovator Transitions Life-cycle Management Medical Research is an “acquisition process” • • • • Early discovery and concept Research (through completed prototye – TRL 6) Commercialization (including purchasing by users) Maintenance and sustainment Implication to researchers of “acquisition process” • • • • Early research – need to consider long term needs Research and development – understand transition strategies Commercialization – about 90% to bring a product to market Maintenance & sustain – did the research plan for this? What is radically new? Classic Education and Examination What is the REVOLUTION in Medical Education? Training for New Technical Skills Halstedian Model: See One, Do One, Teach One SURGICAL EDUCATION The Revolution is ... Now Roughly 100 year cycles (1908 – Flexner Report) It’s all about . . . Improved Patient Care through Manikin Virtual Reality Advanced Surgical Education The New Mandates Effective 1 July 2008 RRC* All residency programs must have a skills training (simulation) center 1 July 2009 ABS All surgical residents must pass FLS** in order to apply for board certificate * Residency Review Committee (RRC) ** Fundamentals of Laparoscopic Surgery Accreditation Council of Graduate Medical Education Approved by American Board of Medical Specialties Two Components of the Revolution Using Modeling and Simulation • Objective Training of Technical Skills Simulators Curriculum • (technology) (training method) Assessment of Cognitive and Technical Skills Criterion-based tools Objective metrics Technology Current areas of simulation Models, tissue, animals VR Manikin CAI Virtual Virtual Live Constructive O SATS Methodology Objective StructuredAssessment of Technical Skills Richard Reznick, Univ of Toronto - 1998 It’s not the Simulator It’s the Curriculum Standardized Curriculum Suggested template • • • • Goals of the Simulation Anatomy Steps of the Procedures Errors TEST • Skills Training • Outcomes The 6 Competencies 2003 Consensus by the AGCME & ABMS • Knowledge • Patient Care • Interpersonal and communication skills • Professionalism • Practice-based learning and improvement • Systems-based practice Mandates Recent mandates include: Sept, 1999 NBME June, 2008 ACGME (RRC) July, 2009 - Medical students required to pass OSCE - All residency programs must have access to a simulation center Amer Board Surg - All residents must complete and document Fundamentals of Laparoscopic Skills course or have board certification application returned Recent initiatives (curricula) to meet mandates Amer Coll Surg - Fundamental Skills Courses to meet ABS reqs - Amer Soc Anes - Basic, advanced surgical skills, team training Airway management, etc - esp team training Maintenance of Certification (MoC) - Retraining of all types Redeployment, pregnancy sabbatical, etc S C O R E ACS/APDS Core Curriculum Three Phases Phase Product Complete •Phase1 Basic Skills Curricula July, 2007 •Phase 2 Full Procedures July, 2008 •Phase 3 Team Training July, 2009 ABS Training/Assessment Website Provides educational/training resources Clearly states expected performance outcomes (quantitative) ACS/APDS Core Curriculum Twenty Basic Skills Asepsis & Instrument Identification . Suturing Advanced Tissue Handling: Flaps Skin Grafts Airway Management Central Line Insertion, Arterial Lines Vascular Anastomosis Principles of Bone Fixation & Casting Endoscopy . Basic Laparoscopy Skills Hand Sewn GI Anastomosis Knot Tying . Tissue Handling Dissection, Wound Closure, Wound Mgmt Catheterization, Uretheral and Suprapubic Chest Tube/Thoracentesis Surgical Biopsy Laparotomy Opening/Closure Introduction: Inguinal Anatomy Upper Colonoscopy Advanced Laparoscopy Skills Stapled GI Anastomosis Pre-operative Warm-up Surgical Rehearsal Courtesy Jacques Marescaux, IRCAD, Strasbourg France Nurses Residents of ER Hand-off OR Hand-off ICU Second Life Comprehensive Curriculum Basic Skills Simple Procedures Advanced Procedures Team Training Task Deconstruction Continuity of Care Why should we do this? Historically Medical education occurs in 100 yr cycles (Flexner 1910) If don’t act now, miss “window of opportunity” Standardization Everyone is “starting from scratch”, so everyone must change Unique opportunity to have ‘International’ standards Paradigm Shift Competency (criterion) based training and assessment ? Totally change structure of system (eg time-based) Ethical Implications Credentialing every surgeon, every procedure? Patient Safety assurance for our patients? Animals for training still needed, but reduced? Quality Assurance promising too much? And just what are these incredible new technologies? Information Representation of a Patient Medical equivalent of CAD/CAM Holomer Total body-scan for total knowledge Virtual Soldier Program Multi-modal total body scan on every trauma patient in 15 seconds Satava March, 2004 Total Integration of Surgical Care Minimally Invasive & Open Surgery Remote Surgery Pre-operative planning Surgical Rehearsal Simulation & Training Pre-operative Warmup Intra-operative navigation Courtesy of Joel Jensen, SRI International, Menlo Park, CA The Fundamental Change From tissue and instruments to Information and energy* * “The Information Age is about changing from objects and atoms to bits & bytes” Nicholas Negroponte “Being Digital” - 1995 Replacing human body parts Intelligent Prostheses Tissue Engineering Artificial Ear a) Rheo Bionic knee Ossur, Reyknavik, Iceland b) C-leg Otto Bock, Minneapolis, MN Liver Scaffolding J. Vacanti, MD Artificial Blood Vessel MGH March, 2000 Organs which have been grown synthetically Commercial Products Neo-bladder – a commercial synthetic bladder A surgeon takes a small, full-thickness biopsy from the patient’s bladder. urothelial and smooth muscle cells that are capable of regeneration are isolated. The isolated cells are cultured separately until there are a sufficient quantity. The cultured cells are properly seeded onto a biodegradable scaffold shaped like a bladder. The biodegradable scaffold dissolves and is eliminated from the body, leaving a functioning bladder made only of the patient’s own newly regenerated tissue. The body uses the neo-bladder construct to regenerate and integrate new tissue, restoring the bladder’s functionality. The neo-bladder construct is implanted by the surgeon using standard surgical techniques. Quality assurance that the cells attach and grow properly throughout the scaffold. After about 8 weeks, the neo-bladder construct is returned to the surgeon for implantation. Tegion, Tengion Courtesy of East Norrington, PA 2007. Genetically re-engineering the body Orb spider - web Spinnerette of spider Spider silk protein as biomaterial -BioSteel Cross section of synthetic fiber Nexia Biotechnologies, Montreal Canada Suspended Animation ( Auto-anesthesia - FRAMR ) Institute of Arctic Biology’s Toolik Field Station, Alaska's North Slope heart rate active hibernating 300 3 (beats/min) resp. rate 150 <1 (breaths/min) body temp. gene function metabolic rate 37oC -2oC ongoing transcription and translation suppressed 0.5 0.01 (2%) (mlO2/g/h) Brian M. Barnes, Institute of Arctic Biology , University of Alaska Fairbanks 11/02 The Moral Dilemma Technology is Neutral - it is neither good or evil It is up to us to breathe the moral and ethical life into these technologies And then apply them with empathy and compassion for each and every patient Human embryos cloned Chinese Cloning Control Required Tuesday 16 April, 2002, 10:41 GMT 11:41 UK Strict ethical guidelines are needed in China to calm public fears about new cell technologies such as cloning, the country's leading scientist said. Professor Ching-Li Hu, the former deputy director of the World Health Organization, was speaking at the Seventh Human Genome Meeting in Shanghai. His call follows recent reports that Chinese scientists are making fast progress in these research fields. One group in the Central South University in Changsa is said to be producing human embryo clones, while another team from the Sun Yat-sen University of Medical Sciences in Guangzhou is reported to have fused human and rabbit cells to make tissues for research. February 12, 2004 South Korean team demonstrates cloning efficiency for humans similar to pigs, cattle | Thersa Tamkins After outlandish claims, a few media circuses, and some near misses by legitimate researchers, a team of South Korean researchers reports the production of cloned human embryos. The findings, were released Wednesday (Science, DOI:10.1126 /science.1094515, February 12, 2004).Wook Suk Hwang and Shin Yong Moon of Seoul National University used somatic cell nuclear transfer to produce 30 human blastocysts and a single embryonic stem cell line; SCNT-hES1. Using 242 oocytes and cumulus cells from 16 unpaid donors, the group achieved a cloning efficiency of 19 to 29%, on par with that seen in cattle (25%) and pigs (26%). Jeffery Steinberg, MD Fertility Institutes of Los Angeles Genetically “designed” child 1997 Five "designer babies" created for stem cell harvest Five healthy babies have been born to provide stem cells for siblings with serious non-heritable conditions. Preimplantation Genetic Screening General Science: May 13, 2006 A British woman has become the first in the country to conceive a "designer baby" selected specifically to avoid an inherited cancer, This is the first time "savoir siblings" have been created to treat children whose condition is not genetic, says the medical team.The five babies were born after a technique called preimplantation genetic diagnosis (PGD) was used to test embryos for a tissue type match to the ailing siblings, reports the team, led by Anver Kuliev at the Reproductive Genetics Institute in Chicago, US.The aim in these cases was to provide stem cells for transplantation to children who are suffering from leukaemia 'Unlawful and unethical' However, the use of this technology to provide a "designer baby" to treat an ill sibling is Science Vol 315: 1723-25, Mar 2007 highly controversial.A UK couple involved in this Gregory Stock The woman, who was not identified, used controversial genetic screening technology to ensure she does not pass on to her child the condition retinoblastoma, an hereditary form of eye cancer from which she suffers. Emergence of Novel Color Vision in Mice Engineered Doctors tested embryos created by the woman and her partner using in-vitro fertilisation (IVF) methods to Express Human Cone Photo-pigment for the cancer gene. Only unaffected embryos were implanted in her womb, the newspaper said. Changes in the genes encoding sensory recptor proteins are an essential step in It suggested the woman's pregnancy would the evolution of new sensory capacities“new sensory capacities" . In primates, triincrease controversy over the procedure -- prechromatic color vision evolved aftre changes in x chromosome linked photopigment genes. implantation genetic diagnosis (PGD) -- because Heterogous mouse females whose retinas contained both mouse pigment and critics say it involves destroying otherwise healthy human humanLLpigments pigments showed enhanced long-wavelength sensitivity and chromatic embryos whose conditions are treatable. discrimination. An inherent plasticity in the mammalian visual system thus permits emergence 1. Verlinsky Y, Rechitsky S, Sharapova T, Morris R, Taranissi M and Kuliev A. Preimplantation HLA Testing. JAMA (2004) 29: 2079 Extending Longevity Life extension A strain of mice that have lived . . . . . . more than three normal lifespans Should humans live 200 years? April 14, 2004 Life extension consists of attempts to extend human life beyond the natural lifespan. So far none has been proven successful in humans. Several aging mechanisms are known, and antiaging therapies aim to correct one or more of these: Dr. Leonard Hayflick discovered that mammalian cells divide only a fixed number of times. This "Hayflick limit" was later proven to be caused by telomeres on the ends of chromosomes that shorten with each cell-division. When the telomeres are gone, the DNA can no longer be copied, and cell division ceases. In 2001, experimenters at Geron Corp. lengthened the telomeres of senescent mammalian cells by introducing telomerase to them. They then became youthful cells. Sex and some stem cells regenerate the telomeres by two mechanisms: Telomerase, and ALT (alternative lengthening of telomeres). At least one form of progeria (atypical accelerated aging) is caused by premature telomeric shortening. In 2001, research showed that naturally occurring stem cells must sometimes extend their telomeres, because some stem cells in middle-aged humans had anomalously long telomeres. CAN I REPLACE MY BODY ? Artificial organs Smart Prostheses Genetic engineering Regeneration If I replace 95% of my body . . . . . . Am I still “human”? Should there be replacement “parts” for astronauts? Moral and Ethical Issues Raised by Technological Success will take DECADES of debate Summary of Examples Should we do research in areas we may not be able to control? (eg, genetics, cloning, nanobots, intelligent machines?) Will prolonging life result in more disease in the overall population Can we change medicine from treatment to prevention of disease In defeating diseases, will technology change a human into a combination of man and machine - what does it mean to be “human” How will we decide who gets the technology, especially in 3rd World 6 SATAVA 7 July, 1999 DARPA The Ultimate Ethical Question? For the first time in history, there walks upon this planet, a species so powerful, that it can control its own evolution, at its own time of choosing … … homo sapiens. Who will be the next “created” species? http://depts.washington.edu/biointel Do Robots Dream ? SMIT2009 MIRA2010 January 27-30, 2010 San Diego, CA - Manchester Grand Hyatt CALL FOR ABSTRACTS DEADLINE: August 14, 2009 Program Chair: Santiago Horgan, MD Minimally Invasive Robotic Association (MIRA) MISSION To raise the level of robotic surgery care in the world. Sinaia, Romania, 7-9 October 2009 As a multidisciplinary association, MIRA invites not only surgeons, but also internists, radiologist, engineers and computer scientists, interested in robotics, telerobotics, telepresence, teleconferencing and telementoring, to join the association and take part in the 2010 International Congress.